Globus Medical (GMED) announced an update on their ongoing clinical study.
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Globus Medical (GMED) is recruiting participants for a post-approval clinical study titled A Prospective, Single-Arm, Multi-Center, Registry Post-Approval Study of Growth Modulation in the Treatment of Idiopathic Scoliosis With the REFLECT™ Scoliosis Correction System. The study aims to evaluate clinical and radiographic outcomes for 100 patients with idiopathic scoliosis using the REFLECT™ Scoliosis Correction System, a device specifically designed to correct spinal alignment while supporting natural growth and mobility. The findings could validate the device’s safety and efficacy in ongoing patient care.
The REFLECT™ Scoliosis Correction System is a non-rigid, HDE-approved device that holds spinal segments in a more anatomically natural position, facilitating both correction and continued spinal mobility. The intervention is intended for patients diagnosed with idiopathic scoliosis.
The study follows a single-arm, prospective design with no masking, meaning all participating patients receive the same treatment, and outcomes will be compared across this group. Its primary goal is treatment-oriented, focusing on the device’s effectiveness and safety within this specific population.
Key dates include a start date of March 1, 2024, with an expected primary completion by December 2025. The most recent study update was officially submitted on December 15, 2025. These markers indicate the study is in its early stages but progressing as planned.
This update could bolster investor confidence in Globus Medical’s innovative scoliosis treatment solutions, as success in this trial may broaden the potential market reach of the REFLECT™ system. Amid competitive pressures in the orthopedic device space, positive results could uniquely position Globus against peers in growth-modulating technologies, potentially boosting its market share and stock performance.
The study remains ongoing, and further updates are available on the ClinicalTrials portal.